Why Does Instrument Pre-Cleaning Continue To Be A Challenge?

For over 25 years the Centers for Disease Control and Prevention (CDC) has been reporting that surgical infections (SSIs) are one of the leading causes of morbidity and mortality among hospital patients in the United States. Within the United States, surgical infections (SSIs) take over 30,000 lives a year.(1)  To help put the problem of SSIs into perspective “It is estimated that 1 in 24 patients who undergo inpatient surgery in the US had a postoperative SSIs.”2 The website HealthyPeople.gov points out that among hospitalized patients, surgical infections are leading causes of preventable deaths in the U.S. The on-going battle against surgical infections is a major focus for healthcare personnel throughout the country.3 A significant source of surgical infections continues to be surgical instruments that remain contaminated after processing and are then returned to surgery. Microscopic bioburden along with biofilms are invisible to the human eye. Consequently, while instruments may appear to be clean after processing, they are in fact still contaminated with organic debris. When deposited in a patient from a contaminated instrument, this dead, sterile organic debris becomes the source of a painful, dangerous and costly surgical infection. In one study “Investigators found 91% of the instruments to be clean visually but, when examined microscopically, 84% of the instruments had residual debris. Sites that contained residual debris included junctions between insulating sheaths and activating mechanisms of laparoscopic instruments and articulations and grooves of forceps. More research is needed to understand the clinical significance of these findings and how to ensure proper cleaning.”4 The cleaning of surgical instruments is defined as the process of removing foreign material (e.g., bioburden, biofilm) from the instruments and is usually accomplished using water with detergents or enzymatic products that are suitable for use. Surgical instruments must be thoroughly cleaned before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. As readers of this blog know, “If it’s not clean, it can’t be safe!” The first step in instrument cleaning begins with a review of the manufacturer’s Instructions For Use (IFUs). Section 7.3 of AAMI’s ST 79 addresses a medical device manufacturer’s responsibilities when it comes to decontaminating and cleaning their devices. Specifically, the manufacture must provide IFUs for the cleaning of the device utilizing methods and equipment available in any healthcare facility.(5) The Association of periOperative Registered Nurses (AORN) “Guideline for Cleaning and Care of Surgical Instruments” identifies actions that must be taken by perioperative personnel to comply with AAMI ST 79. Recommendation III in the AORN guideline states that instruments should be cleaned and decontaminated as quickly as possible after use. Section III(a) of AORN’s Guideline discusses the need for cleaning instruments at the point of use as soon as possible. “The goal of cleaning at the point of use is the removal of all gross bioburden. Then instruments are to remain moist (either from a water-soaked towel, enzymatic treatment or other method to maintain humid conditions) to prevent them from drying.”6 Given that manufacturers’ IFUs, AAMI’s ST79, the AORN Guidelines along with The Joint Commission’s requirements all call for pre-cleaning instruments at point-of-use, why doesn’t it consistently happen in every healthcare facility? A recent study (2017) by the Pennsylvania Patient Safety Authority addressed this very question and found some interesting answers and observations to this important question. Specifically, the study found: “The following problematic, common themes emerged during interviews with individuals involved in surgical instrument reprocessing and use:

• Reprocessing staffing patterns not aligned with increases in surgical case loads
• Unrealistic expectations related to reprocessing production pressure (demands for quicker turnaround of instruments)
• Subpar levels of surgical instrument stock
• Re-processors' unfamiliarity with manufacturer's instructions for use and care of instruments
• Operating room staff not consistently wiping, precleaning, or soaking instruments prior to sending for reprocessing
• Used surgical instrument trays sitting for prolonged periods of time before being sent for reprocessing
• The operating room and reprocessing departments treated as separate teams—a lack of cohesiveness between departments
• Lack of standardized training and education
• Poor workflow design in the reprocessing department
• Inconsistent auditing of process measures and quality indicators” (7)

Based on the results of this study, the question for you and your staff is “Does pre-cleaning of surgical instruments consistently happen at your facility and if not, why not?” Your answer to this question will have a significant impact on your patients and their risk of contracting a costly, dangerous and painful surgical infection from a contaminated instrument.   1 https://www.cdc.gov/   2 Spruce, Lisa DPN (2014, May). Back to Basics: Preventing Surgical Site Infections.   3 https://www.healthypeople.gov/   4 DesCoteaux JG, Poulin EC, Julien M, Guidoin R. Residual organic debris on processed surgical instruments. AORN J. 1995; 62:23-30. 5 AAMI ST 79, 2017   6 AORN’s “Guideline for Cleaning and Care of Surgical Instruments” Section III(a)   7 “Retained Bioburden On Surgical Instruments After Reprocessing: Are We Just Scraping the Surface?” Pa Pat Saf Advis 2017 Jun; 14(2): 71-75